Health product recall

Aplio-500, Aplio-1600, Aplio-1700, Aplio-1800, Aplio-1900, and Aplio-A450 Diagnostic Ultrasound System (2019-04-02)

Starting date:
April 2, 2019
Posting date:
April 29, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69722

Last updated: 2019-04-30

Affected Products

A. Aplio 500 - Main Unit
B. Aplio-1700 - Main Unit
C. Aplio-1800 - Main Unit
D. Aplio-1900 - Main Unit
E. Aplio-1600 - Main Unit
F. Aplio-A450 Diagnostic Ultrasound System

Reason

Some option kits were shipped with expired parts.

Affected products

A. Aplio 500 - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

TUS-A500

Companies
Manufacturer
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN

B. Aplio-1700 - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

TUS-AI700

Companies
Manufacturer
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN

C. Aplio-1800 - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

TUS-AI800

Companies
Manufacturer
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN

D. Aplio-1900 - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

TUS-AI900

Companies
Manufacturer
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN

E. Aplio-1600 - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

TUS-AI600

Companies
Manufacturer
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN

F. Aplio-A450 Diagnostic Ultrasound System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

CUS-AA450

Companies
Manufacturer
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN